American Pharmaceutical Review: A Russell Publishing Publication

November/December 2006

Articles

• Differentiating Authentic Manufacturers of Active Pharmaceutical Ingredients Using a Variety of Techniques

  ¹Caroline Machal Kelley, Brenda S. Zimmer, Ph.D., Valerie M. Toomey, Mary B. Jones, Samuel R. Gratz, Ph.D., and ²Robert Prestridge
  ¹Forensic Chemistry Center, U.S. Food and Drug Administration
  ²Therapeutic Goods Administration, Australia

• Considerations for Successfully Replacing a Chromatography Data System (CDS) in a Regulated Environment

  Anthony Pecora
  Wyeth Consumer Healthcare

• Leachable Study on Solid Dosage Form

  Xueguang Fang, Nick Cherico, Damon Barbacci, Angela M. Harmon, Matt Piserchio and Holly Perpall
  Merck & Co., Inc.

• Opportunities for Rapid Microbial Methods

  Anthony M. Cundell, Ph.D.
  Consulting Microbiologist

• Optical Imaging Biomarkers in Drug Discovery

  Bohumil Bednar, Cyrille Sur
  Imaging Department, Merck Research Laboratories

• From Molecules to Pharmaceutical Products – The Drug Substance/Drug Product Interface

  Martyn Ticehurst and Robert Docherty
  Pharmaceutical Sciences, Pfizer Global R&D, Sandwich, Kent, UK

• Delivery Strategies to Support Development of Peptide Therapeutics

  Aleksander Swietlow, Ph.D. and Paul Burke, Ph.D.
  Pharmaceutics, Amgen, Inc

• Technical Considerations in the Development of Prefilled Syringes for Protein Products

  David E. Overcashier, Edwin K. Chan, and Chung C. Hsu
  Late Stage Pharmaceutical and Device Development
  Genentech, Inc

• Impurity Identification in Pharmaceuticals

  Thomas R. Sharp
  Analytical R&D Department,
  Pfizer Global Research & Development

• Use of Disposable Technology in Biologics Manufacture

  Annette Koch, Christelle Wittische-Laroche, Elodie De Roo and Alain Pralong
  F. Hoffmann-La Roche Ltd

• On the Way to Rational Freeze-Drying

  Yves Mayeresse and Romain Veillon
  GlaxoSmithKline

• Raman Applications in Drug Manufacturing Processes

  Dimuthu Jayawickrama, Arwa El Hagrasy and Shih-Ying Chang
  Pharmaceutical Research Institute, Bristol Myers Squibb Co.

• Near-Infrared Spectroscopy: Why It Is Still the Number One Technique in PAT

  Emil W. Ciurczak
  Cadrai Group